Curated News
By: NewsRamp Editorial Staff
December 27, 2024

Clene Receives FDA Guidance for Accelerated Approval Pathway for CNM-Au8 in ALS

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Source News Release

TLDR

  • Clene Inc. received written guidance from FDA for potential accelerated approval of lead drug CNM-Au8 in ALS, giving them a competitive advantage in the neurodegenerative disease treatment market.
  • The FDA provided guidance following a Type C meeting, recommending leveraging Neurofilament Light data from Expanded Access Programs to support earlier findings.
  • Clene Inc.'s lead drug candidate CNM-Au8 in ALS has the potential to improve the lives of critically ill patients and their families, offering hope for those suffering from neurodegenerative diseases.
  • The FDA's guidance on potential accelerated approval for Clene Inc.'s lead drug candidate CNM-Au8 in ALS represents a significant step forward in the treatment of neurodegenerative diseases.

Impact - Why it Matters

This news matters as it provides insight into the potential accelerated approval of a drug candidate for ALS, a debilitating neurodegenerative disease. The FDA guidance indicates progress in the development of a therapy that could significantly impact ALS patients and their families.

Summary

Clene (NASDAQ: CLNN) and its subsidiary, Clene Nanomedicine Inc., received FDA guidance for potential accelerated approval of their lead drug candidate CNM-Au8 in ALS. The guidance followed a Type C meeting where Clene presented additional clinical trial data and analyses. Clene plans to submit an NDA under the accelerated approval pathway in mid-2025.

CEO Rob Etherington expressed optimism, citing the drug's safety profile and supportive biomarker data. The company remains dedicated to the ALS community and looks forward to continued discussions with the FDA.

Source Statement

This curated news summary relied on this press release disributed by InvestorBrandNetwork (IBN). Read the source press release here, Clene Receives FDA Guidance for Accelerated Approval Pathway for CNM-Au8 in ALS

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